We are looking for a motivated CSV Validation Executive to support validation activities for computerized systems in the pharmaceutical domain. The candidate will assist in ensuring compliance with regulatory requirements such as GxP, FDA 21 CFR Part 11, and EU Annex 11 .
Key ResponsibilitiesAssist in Computer System Validation (CSV) lifecycle activities
Prepare, review, and execute validation documents:
User Requirement Specifications (URS)
Functional Specifications (FS)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Support validation of systems like:
LIMS
ERP (SAP)
Laboratory instruments software
Ensure compliance with GxP guidelines
Participate in risk assessments and validation planning
Maintain proper documentation as per regulatory standards
Support audits and inspections (internal/external)
Coordinate with cross-functional teams (QA, IT, Manufacturing)
Bachelor's degree in:
Pharmacy (B.Pharm / M.Pharm)
Life Sciences
Biotechnology
Computer Science / IT (preferred for technical roles)
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